28.05.2019

Mortality Not Correlated With Paclitaxel Exposure

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A new study of designated physicians determines that there is no correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up!

Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon

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Background

Five years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years.

Objectives

The purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up.

Methods

Data from 2 single-arm and 2 randomized independently adjudicated prospective studies of a paclitaxel DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA) (n = 143) were included. Analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations of paclitaxel dose with long-term mortality. Survival time by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. A standard cohort was defined to compare DCB- and PTA-treated patients with similar characteristics by applying criteria from pivotal studies (n = 712 DCB, n = 143 PTA).

Results

A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0, 10,007.5, and 19,978.2 μg, respectively. Rates of freedom from all-cause mortality between the 3 groups through 5 years were 85.8%, 84.2%, and 88.2%, respectively (p = 0.731). There was no significant difference in all-cause mortality between DCB and PTA through 5 years comparing all patients (unadjusted p = 0.092) or patients with similar characteristics (adjusted p = 0.188).

Conclusions

This independent patient-level meta-analysis demonstrates that this paclitaxel DCB is safe. Within DCB patients, there was no correlation between level of paclitaxel exposure and mortality. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I], NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II], NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA], NCT01947478; The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population, NCT02118532; and IN.PACT Global Clinical Study, NCT01609296)

Central Illustration

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24.05.2019

EFFPAC: 24-month outcomes

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EFFPAC RCT 24-month outstanding results with Luminor DCB have been revealed at EuroPCR 2019.

Effectiveness of LuminorDCB vs. POBA in the SFA:24-month safety and efficacy outcomes

Paris, May 21st, 2019 – EFFPAC RCT 24-month outstanding results with Luminor DCB have been revealed at EuroPCR 2019.

The 24-month results from the full clinical cohort of the EFFPAC randomized controlled trial (RCT), were presented for the first time at EuroPCR 2019 on May 21st.

Main objective was to assess the effectiveness of Luminor drug coated balloon (DCB) vs. Uncoated balloon catheter (POBA), in the superficial femoral and popliteal arteries. The EFFPAC RCT 24-month outcomes are all demonstrating high statistical significance versus POBA, therefore confirming and even maintaining, the already excellent 12-month outcomes:

To view the complete presentation from Prof. Teichgräber about EFFPAC trial at EuroPCR 2019
<< CLICK HERE >>

04.10.2018

Alvimedica NiTiDES @ CIRSE 2018

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NiTiDES is a polymer free stent-eluting the amphilimus formulation (a combination of sirolimus and fatty acid) through the “Abluminal Reservoir Technology” aiming at obtaining the highest efficacy profile for the patient

Alvimedica NiTiDES @ CIRSE 2018

NiTiDES is a polymer free stent-eluting the amphilimus formulation (a combination of sirolimus and fatty acid) through the “Abluminal Reservoir Technology” aiming at obtaining the highest efficacy profile for the patient. The polymer-free platform, which is made of nitinol, is integrally covered by the Bio Inducer Surface coating, a second generation pure carbon “ultra thin” layer that drastically increases haemo- and biocompatibility.

Alvimedica NiTiDES – Platform characteristics / Dr. Ralf Langhoff, St. Gertrauden Hospital, Berlin

ILLUMINA Study – NiTiDES First In Human Trial / Prof. Dr. Dierk Scheinert, University Hospital Leipzig

Watch the complete Satellite Symposium @ CIRSE Library

02.05.2018

luminor – The best DCB ever!

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EFFPAC RCT 12-month outstanding results with Luminor DCB have been revealed at CX Symposium 2018.

EFFPAC RCT 12-month outstanding results with Luminor DCB have been revealed at CX Symposium 2018

London, April 25th, 2018 – EFFPAC RCT 12-month outstanding results with Luminor DCB have been revealed at CX Symposium 2018.

The 12-month results from the full clinical cohort of the EFFPAC randomized controlled trial (RCT), were presented for the first time at CX Symposium 2018 at the DCB session on April 24th.

Main objective was to assess the effectiveness of Luminor drug coated balloon (DCB) vs. Uncoated balloon catheter (POBA), in the superficial femoral and popliteal arteries. The EFFPAC RCT 12-month outcomes are all demonstrating high statistical significance versus POBA, therefore confirming and even maintaining, the already excellent 6-month outcomes:

To view the complete presentation from Prof. Teichgräber @ about EFFPAC trial at CharingX 2018
<< CLICK HERE >>

  • Late Lumen Loss (LLL) at 6 months: 0.14mm
  • Target Lesion Revascularization (TLR) at 12 months: 1.3%
  • Primary Patency (PP) at 12 months: 90.3%
  • Rutherford stage improvement at 12 month: 90.6%